Christopher Kirk, PhD
Co-Founder, President and Chief Scientific Officer of Kezar Life Sciences
Christopher Kirk, PhD is a scientific and strategic advisor to Juvena Therapeutics. He is the co-founder, President and Chief Scientific Officer of Kezar Life Sciences, a publicly traded company developing first-in-class, small molecule therapies designed to inhibit multiple disease-driving cellular pathways by targeting key intracellular proteins. Dr. Kirk is an immunologist and tumor biologist by training. Prior to founding Kezar, he was the Vice President of Research at Onyx Pharmaceuticals where he played a key leadership role in the discovery and development of 2 proteasome inhibitors, including carfilzomib (KYPROLIS™), currently approved for the treatment of multiple myeloma. Dr. Kirk has authored multiple publications in several select journals including Cell, Nature Medicine, and Nature Reviews and is listed as an inventor on over 40 patents. He sits on the scientific advisory board at C4 Therapeutics, Avidity Biosciences, Rain Therapeutics, the Institute of Applied Clinical Science at the M.D. Anderson Cancer Center as well as the leadership council of the Life Sciences Institute of the University of Michigan.
Dr. Kirk received his B.S. in Biochemistry from the University of California, Davis, and his Ph.D. in Cellular and Molecular Biology from the University of Michigan.
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JOSEPH MILETICH, MD, PHD
Former SVP, Research Sciences, at Merck
Joseph Miletich, MD, PhD, is a former SVP, Research Sciences, at Merck. He has more than 20 years of combined experience at Merck and Amgen leading programs through Discovery Research, Preclinical Development and Translational Medicine/Early Development. At both companies, Dr. Miletich focused on building teams and investing in technologies, partnerships and acquisitions to enable capitalizing on new insights into biology regardless of therapeutic area or modality. Dr. Miletech currently serves as advisor and board director to several companies and firms. Most recently, Dr. Miletich was Merck Research Laboratories’ senior vice president of research sciences and is currently senior scientific advisor to Merck’s CEO, an advisor to Recursion, and a director to Flame Biosciences, among other roles. . Prior to his last 8+ years at Merck Research Laboratories, Dr. Miletich served as senior vice president of research and development at Amgen.
Dr. Miletich received his M.D. and Ph.D. degrees from Washington University in St. Louis and pursued clinical training in internal medicine at the University of California in San Francisco. Subsequently he joined the faculty at Washington University, pursued subspecialty training in clinical hematology and in laboratory medicine, and developed a leading research effort in hemostasis and thrombosis. Over a 17 year career, he rose through the ranks to become Professor of Medicine and Pathology and Head of the Division of Laboratory Medicine at Washington University, in which capacity he was responsible for the combined laboratories of the Barnes-Jewish Hospital system, one of the nation’s largest clinical laboratories.
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Nicholas E. Johnson, MD, MSCI, FAAN
Neuromuscular Clinical Advisor; Professor and Vice Chair of Research, Neuromuscular Diseases, VCU
Nicholas E. Johnson, MD, MSCI, FAAN is an associate professor, division chief of neuromuscular, and vice chair of research in the department of neurology at Virginia Commonwealth University with a focus in inherited neuromuscular disorders. He received his undergraduate degree in molecular and cellular biology and psychology at the University of Arizona. He then obtained his medical degree at the University of Arizona. He completed his neurology residency and combined fellowship in neuromuscular medicine and experimental therapeutics at the University of Rochester. His laboratory is focused on identifying the pathogenesis of myotonic dystrophy, the limb girdle muscular dystrophies, and facioscapulohumeral muscular dystrophy and identifying appropriate clinical endpoints for these conditions. Johnson conducts therapeutic trials in many other inherited nerve and muscle disorders.
Translational laboratory focused on identifying genetic modifiers across muscular dystrophies, and developing clinical endpoints and patient reported outcomes for myotonic dystrophy, facioscapulohumeral muscular dystrophy, and the limb girdle muscular dystrophy. The laboratory uses cellular models to identify changes in RNA splicing in myotonic dystrophy.
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David Schaffer, PhD
Professor, UC Berkeley, Director, Berkeley Stem Cell Center, co-founder, 4D Molecular Therapeutics; Director, Bakar BioEnginuity Hub
David Schaffer is a Professor of Chemical and Biomolecular Engineering, Bioengineering, and Neuroscience at UC Berkeley, where he also serves as the Director of the Berkeley Stem Cell Center. In addition, he is Co-Founder, Acting CSO, and Co-Chairman of 4D Molecular Therapeutics.
At UC Berkeley, Dr. Schaffer applies engineering principles to enhance stem cell and gene therapy approaches for neuroregeneration, work that includes novel approaches for molecular engineering and evolution of new viral vectors as well as new technologies to investigate and control stem cell fate decisions.
Professor Schaffer served as Dr. Yousef’s co-thesis advisor (2008-2013).
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Irina Conboy, PhD
Professor, Bioengineering, UC Berkeley
Irina Conboy is a Professor at the University of California, Berkeley in the Department of Bioengineering. Her discovery of the rejuvenating effects of young blood through parabiosis in a seminal paper published in Nature in 2005 paved the way for a thriving field of rejuvenation biology. The Conboy lab currently focuses on broad rejuvenation of tissue maintenance and repair, stem cell niche engineering, elucidating the mechanisms underlying muscle stem cell aging, directed organogenesis, and making CRISPR a therapeutic reality.
Professor Conboy served as Dr. Yousef’s co-thesis advisor (2008-2013).
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Peter Jackson, PhD
Professor, Stanford School of Medicine, former Director, Genentech
Peter Jackson is a Professor in the Baxter Laboratory for Stem Cell Biology, Department of Microbiology & Immunology, at the Stanford University School of Medicine. Dr. Jackson returned to Stanford in 2013 after eight years as a Staff Scientist and Director at Genentech Inc. in S. San Francisco, California. At Genentech, he helped define and implement the development of therapeutics for cancer pathways including cell cycle checkpoints, stress pathways, and tumor metabolism. Before joining Genentech in 2005, he spent 10 years on the faculty at Stanford University School of Medicine. His laboratory has been involved in studies of cell cycle biochemistry, regulation of the cancer by kinases and phosphatases, the ubiquitin-proteasome system, and the discovery of a new physiological class of competitive (“pseudosubstrate”) E3 ubiquitin ligase inhibitors, exemplified by the APC/C regulator Emi1.
Since 2005, his lab has focused on signaling through the primary cilium, using proteomic approaches to define regulatory networks and new disease genes. More broadly, the lab has connected many proteins defective in human diseases and cancer to new complexes and pathways, with a view to discovering molecular signatures for diagnostics and therapeutic development. His research has earned him numerous visiting lectureships and honors, including awards from the Baxter Foundation, Howard Hughes Medical Institute, the American Cancer Society, the Pluto Society, and being a Stanford Hume Faculty Scholar and a Kirsch Scholar, and elected a Fellow of the American Association for the Advancement of Science (in 2008).
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Joe Wu, MD, PhD
Professor, Stanford School of Medicine, Director, Stanford Cardiovascular Institute
Joseph C. Wu, MD, PhD, is Director of the Stanford Cardiovascular Institute and Simon H. Stertzer Endowed Professor in the Departments of Medicine (Cardiology) and Radiology at Stanford School of Medicine. Dr. Wu received his medical degree from Yale. He completed his medicine internship, residency, and cardiology fellowship (STAR program) at UCLA. He obtained his PhD in the Department of Molecular & Medical Pharmacology with Dr. Sam Sanjiv Gambhir. His clinical interests include adult congenital heart disease and cardiovascular imaging.
His lab works on biological mechanisms of patient-specific and disease-specific induced pluripotent stem cells (iPSCs) with a focus on cardiovascular disease mechanisms and the implementation of precision medicine for prevention and treatment of cardiovascular patients. His lab uses a combination of genomics, stem cells, cellular & molecular biology, physiological testing, and molecular imaging technologies. Dr. Wu has published >400 manuscripts with H-index of 101 on Google scholar and recognition as top 1% of highly cited researchers in Web of Science (2018, 2019 & 2020). Among his trainees, >30 of them are principal investigators in the US or abroad.
Dr. Wu has received numerous awards, including National Institutes of Health (NIH) Director’s New Innovator Award, NIH Roadmap Transformative Award, American Heart Association (AHA) Innovative Research Award, Presidential Early Career Award for Scientists and Engineers (PECASE) given out by President Obama, AHA Established Investigator Award, Burroughs Wellcome Foundation Innovation in Regulatory Science Award, AHA Merit Award, and AHA Distinguished Scientist Award. Dr. Wu serves on the Scientific Advisory Board for the Keystone Symposia, FDA Cellular, Tissue, and Gene Therapies Advisory Committee, AHA National Board of Directors, and Chair of the AHA National Research Committee.
Dr. Wu is an elected member of American Society of Clinical Investigators (ASCI), Association of University Cardiologists (AUC), American Institute for Medical and Biological Engineering (AIMBE), American Association of Physicians (AAP), American Association for the Advancement of Science (AAAS), and National Academy of Medicine (NAM).
In addition, he has been scientific co-founder of several startups.
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Matthew Fust, MBA
Former CFO Onyx, Jazz, ALZA (merged with J&J); Board member, Neumora, Arsenal Bio, Atara, Ultragenyx
Matthew is an advisor to life sciences companies, executive teams and investors. From 2009 through 2013, he was CFO of Onyx Pharmaceuticals, culminating in the company’s acquisition by Amgen. He previously served as CFO of Jazz Pharmaceuticals (2003 – 2008), CFO of Perlegen Sciences (2002 – 2003), and CFO of ALZA Corporation, where he was an executive from 1996 through the company’s acquisition by Johnson & Johnson in 2001. Prior to joining ALZA, Matthew was a member of the healthcare strategy consulting practice at Andersen Consulting (now Accenture).
He serves on the boards of directors of Atara Biotherapeutics, Crinetics Pharmaceuticals and Ultragenyx Pharmaceuticals. He is also an advisor to Out Leadership/Quorum and Women In Bio.
Matthew holds an undergraduate degree from the University of Minnesota and an M.B.A. from the Stanford University Graduate School of Business.
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Ameet Mallik, MBA
CEO, ADC Therapeutics, Former EVP, US Oncology at Novartis, McKinsey, Wharton
Ameet Mallik is CEO of ADC Therapeutics, and a member of the Board of Directors of Atara Biotherapeutics, where he previously served as its Chief Executive Officer. Prior to that, Mr. Mallik served as Executive Vice President and Head, U.S. Oncology of Novartis. In this role, Mr. Mallik was responsible for Novartis’ commercial and medical oncology operations in the United States. Mr. Mallik also served as Global Head, Marketing, Value and Access, and as Head, Latin America and Canada, both for Novartis Oncology. Mr. Mallik began his career at Novartis as Head of Strategic Planning and has held a number of commercial leadership roles at Novartis and Sandoz. At Sandoz, Mr. Mallik was Global Head of Biopharmaceuticals & Oncology Injectables. Mr. Mallik previously worked as an Associate Principal at McKinsey and Company. Mr. Mallik holds an M.B.A. from The Wharton School at the University of Pennsylvania, and an M.S. in Biotechnology and B.S. in Chemical Engineering, both from Northwestern University.
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Mike Nohaile, PhD
CEO, Prellis Biologics, former CSO, Generate Biomedicines; Former SVP Amgen, Novartis, McKinsey, UC Berkeley, MIT
Mike Nohaile, PhD, is Chief Executive Officer at Prellis Biologics and former Senior Vice President of Strategy, Commercialization & Innovation at Amgen Inc. Dr. Nohaile joined Amgen as Vice President of Strategy in December 2012. Prior to Amgen, he served as the Head and General Manager of the Molecular Diagnostics Business Unit at Novartis. He served Novartis as the Head of Corporate Strategy and Head of Pharmaceutical Strategy.
Mike began his career at McKinsey & Company, as partner in the New Jersey office, where he worked extensively in the healthcare area with a particular focus on diagnostics, devices and pharmaceuticals. He has a doctorate in molecular and cell biology from University of California, Berkeley and he was a postdoctoral fellow at MIT in the Department of Biology.
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Former CEO, Vertias; Stanford GSB, Stanford Healthcare
Mark Leslie is a Lecturer at the Stanford Graduate School of Business where he teaches courses in Entrepreneurship, Ethics and Sales Organization. He is also the managing director of Leslie Ventures, a private investment company, and serves on the boards of public, private and nonprofit organizations.
Mark Leslie was Co-Founder and Chairman and CEO of Veritas Software. During his tenure as CEO, the company went from 12 employees to 6,000 employees, and from a revenue base of $95,000 per year to $1,500,000,000 per year. In 2000, Veritas was the 10th largest independent software company by revenue, third largest by market capitalization, and achieved the distinction of becoming a Fortune 1000 company.
From 1980 until 1990 he served as president and chief executive officer of two Silicon Valley high-tech start-up companies. His prior experience included sales management, sales executive, systems engineer, and software engineer focused on operating systems.
Mark currently serves on the boards of, or is an advisor to. a number of high-tech and biotech companies. Mark is also on the boards of Stanford Health Care, New York University and the Leslie Family Foundation.
Mark received a Bachelor of Arts degree in physics and mathematics from New York University in 1966 and completed Harvard Business School’s Program for Management Development (PMD)in 1980.
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Preclinical and Clinical Consultants
Meredith Brown-Tuttle has written and coordinated numerous drug and biologic
submissions to US and international regulatory agencies, developed global regulatory
strategies, and conducted worldwide regulatory intelligence.
Meredith Brown-Tuttle, RAC, FRAPS, has 31 years of industry experience from bench to clinic to
approval of both drugs and devices. Meredith has written and coordinated numerous drug and
biologic submissions to US and international regulatory agencies, developed global regulatory
strategies and conducted worldwide regulatory intelligence. She is currently both Vice
President of Regulatory & Quality at Lyric Pharmaceuticals, Inc. and a strategy/intelligence
consultant at Regulatoium. Meredith has written, managed and led over 30 successful domestic
and international IND and NDA submissions. She is a founding instructor at UC Santa Cruz
Regulatory Certificate Program and author of two books: “IND Submissions: A Primer” and
“Regulatory Intelligence 101.” Meredith graduated with a BA in biological psychology
(neuroscience) from San Jose State University.
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Joyce James, PhD
Nonclinical and pharmacology consultant; Former VP Early Dev, Odonate; Former VP Clinical Pharmacology, Lyric Pharma; Former Sr. Director Drug Metabolism, PK, Cytokinetics
Joyce James, Ph.D., is a strong leader with over twenty years of industry experience dedicated to the discovery and development of therapeutics, including small molecules, peptides, and biologics. Areas of expertise include nonclinical, early phase clinical trials, and bioanalytical, biomarker, and pharmacodynamic assays to support all stages of development, including related development and regulatory strategy. Founder of Corvid LLC, an early development and clinical pharmacology consulting company. Previously served as Vice President of Early Development and member of the management team for Odonate Therapeutics, an oncology-focused company. Founding and core member of Lyric Pharmaceuticals, serving as Vice President, Clinical Pharmacology & Early Development. Prior to Lyric, served as Senior Director and Head of Drug Metabolism and Pharmacokinetics & Analytical Chemistry at Cytokinetics, supporting numerous research and clinical programs. Held senior positions at Ambit Biosciences, playing a key role in the discovery and development of quizartinib for the treatment of FLT3-ITD positive acute myelogenous leukemia (approved in Japan). Provided critical support for the successful filing of multiple INDs and deep experience in nonclinical and clinical Phase 1 study designs. Consult for a number of biopharmaceutical companies providing ADME, analytical, clinical pharmacology, and bioanalytical support. Began a pharmaceutical career as a Research Fellow at Merck Research Labs, devoting time to both NMR spectroscopy and discovery DMPK. Ph.D. in Biophysical Chemistry, The University of California, Berkeley, Department of Chemistry and B.S. in Biochemistry, The College of Charleston, Department of Chemistry, summa cum laude.
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Jeff Welch has over 30 years of CMC experience in the process development, GMP manufacturing and facilities, and regulatory documentation.
In Jeff’s most recent role as a consultant he has had responsibility for authoring and reviewing regulatory filing sections related to process development and product characterization.
Over the past decade Jeff has focused on his role as a senior director for drug substance (DS) process development and director over process engineering and operations for a specialty pharmaceutical company working in biologics and vaccines and as a CDMO organization.
Jeff has also served as a project manager for large scale manufacturing and technology transfer projects and filled the DS team leader role. After a lead role in engineering and construction, he served as a senior manager over the start up effort for a stainless steel cell culture facility (1600 L scale), where he hired and managed personnel and led a 7-day-a-week cGMP manufacturing operation for the upstream portion.
In his early career he participated in design of a multi-product manufacturing facility and after start-up performed process fit and technology transfer activities for several microbial, yeast and cell culture products.
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Daniel David Gretler, MD
Dr. Gretler is Board Certified in Internal Medicine and Clinical Pharmacology and has worked in drug development for almost 30 years with the last 10 spent as a consultant in clinical pharmacology and early drug development. He received his MD from the University of Bern in his native Switzerland and his graduate medical training in Internal Medicine, Critical Care and Clinical Pharmacology at the University of Southern California and The University of Chicago, where his last position was Assistant Professor in the Committee on Clinical Pharmacology, Section of Cardiology. He started his drug development career at Syntex and held various positions there and later at COR Therapeutics, Millennium Therapeutics and Portola Pharmaceuticals. His last full-time position was Chief Medical Officer at Portola Pharmaceuticals. He has been Adjunct Clinical Associate Professor of Medicine at Stanford University for over 20 years. He has contributed to the development and approval of a number of drugs including CAMZYOS, NULIBRY, OXBRYTA, ANDEXXA, BEVIXXA (betrixaban), INTEGRILIN, CELLCEPT.
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